Barrier and cushioning apparatus for dental radiography

ABSTRACT

A barrier and cushioning apparatus for use with a digital dental x-ray detection sensor or conventional film packet. The apparatus provides an improved degree of comfort, protection and safety for a patient while at the same time avoiding contamination of the sensor. The barrier and cushioning apparatus may be configured in a number of different ways with or without adhesive positioning strips to accommodate various sensor holders, baskets, and other devices used in conjunction with the digital sensor. The barrier and cushioning apparatus may be configured in a number of different ways with bite tabs which allow the patient to hold the sensor or film and oral cushion in place by occluding on the bite tab.

This application is a continuation-in-part application and claims thebenefit of U.S. application Ser. No. 10/854,764, filed on May 26, 2004,now U.S. Pat. No. 7,004,627 and U.S. Provisional Application No.60/529,190, filed on Dec. 12, 2003, both entitled BARRIER AND CUSHIONINGAPPARATUS FOR DENTAL RADIOGRAPHY. The entire disclosure of the priorapplications is considered a part of the disclosure of the accompanyingapplication and is hereby incorporated by reference therein.

BACKGROUND

1. Field of the Invention

The present teachings relate to the field of dental radiography, andmore particularly to an intraoral barrier for digital radiographicsensor devices. The present invention particularly relates to a digitalradiographic sensor device that is comfortable for a patient and easy touse for a dental professional.

2. Description of the Related Art

Digital radiographic sensor systems are increasingly used in the dentalfield as an alternative to conventional film-based acquisition systems.Digital radiographic imaging provides a number of potential benefitsincluding: reduced processing times with rapid imaging results,elimination of film developer chemicals and mounting requirements andthe ability to conveniently perform a number of specialized functionsusing the resultant digital radiographs including; calibrated lengthmeasurement, image enhancement, digital zooming, colorizing, archiving,etc.

Unfortunately, digital radiographic sensors are subject to a number ofusage considerations that should be addressed to improve patient comfortand minimize the potential for contamination of the sensor. For example,most dental sensors are not designed to permit autoclaving orsterilization between uses and their cost preclude one-time disposableuse. As a consequence, a contamination risk exists as the same device istypically intended to be shared between numerous patients. To addressthis problem, dental sensors may be used in conjunction with aprotective barrier, which serves to shield the device from a patient'ssaliva and prevent cross contamination between patients.

Conventional protective barriers are generally formed from a plasticsheath or enclosure which surrounds the dental sensor and may be removedand disposed of after use. One problem with such barriers is that theymay be formed so as to have a seam or edge which may engage or rubagainst the patient's oral tissues creating discomfort during theimaging process. A further problem with such conventional barriers isthat they may be cumbersome to use and/or provide inadequate protectionagainst contamination.

Typically, dental sensors such as those described above are secured to aholder or bite plate during use. The holder or bite plate also possessespotentially hard, rough or sharp edges and may likewise cause patientdiscomfort during use. Properly securing the dental sensor to the holderor bite plate may be additionally complicated by the use of theprotective barrier which may encourage slippage between thesecomponents.

From the foregoing, it will be appreciated that there is a need for animproved protective barrier design to be used in connection with digitalsensors to increase patient comfort and alleviate potential tissueinjury during imaging. Additionally, there is a need to reduce patientdiscomfort arising from the holder or bite plate used in connection withthe digital sensor.

SUMMARY

The aforementioned needs are satisfied by an oral cushioning barrierthat improves patient comfort during radiographic imaging while reducingthe risk of tissue injury resulting from insertion of a radiographicdetection device within a patient's oral cavity. The oral cushion may beformed in a number of different sizes and configurations and adapted foruse with conventional x-ray film packets, as well as, newer digitalx-ray sensors. The oral cushion incorporates an integrated adhesivesection that may be used to secure various positioning accessories tothe cushion so as to facilitate alignment of the radiographic detectiondevice during use. The oral cushion may also be configured to provide agenerally soft barrier about at least a portion of the positioningaccessory further improving patient comfort and reducing the risk oftissue injury. The oral cushion may further be configured tosubstantially enclose the radiographic detection device thereby reducingthe risk of contamination of the device.

In various embodiments, the oral cushion comprises a foam or plasticsheath formed to substantially enclose the radiographic detection devicewithin a cushioning region provided to be positioned about theradiographic detection device and various portions of an associatedpositioning accessory in regions that may potentially engage with theoral tissue of the patient. Additionally, the oral cushion may begenerally constructed in such a manner so as to reduce undesirable bulkthat might otherwise hinder placement of the sensor within a holder,bite plate or within the patient's mouth directly.

In one aspect, the present teachings provide an intra-oral dentalcomfort device capable of being configured for use with a positioningaccessory, the device comprising an oral cushion having first and secondsides with a pocket disposed therebetween, the pocket dimensioned toreceive and maintain a dental sensor in a generally secure positionwithin the oral cushion, the oral cushion further configured to providea comfort barrier between at least a portion of the dental sensor andtissue in a patient's oral cavity; and an adherent member disposed alongat least a portion of the oral cushion, the adherent member configuredto receive and secure the positioning accessory to the oral cushion suchthat the dental sensor may be positioned in a desired orientation withinthe patient's oral cavity allowing imaging of at least a portion of thepatient's teeth by an imaging device used in connection with the dentalsensor.

In another aspect, the present teachings provide a method for improvingthe comfort characteristics of a dental sensor to be used during x-rayacquisition. The method comprising the steps of enclosing at least aportion of the dental sensor with an oral cushion, the oral cushionconfigured to receive the dental sensor in a pocket region of the oralcushion whereby the dental sensor is retained in a generally secureposition within the oral cushion; securing a positioning accessory tothe oral cushion using an adherent member disposed along at least aportion of the oral cushion such that the dental sensor may bepositioned in a desired orientation within the patient's oral cavity;and positioning a comfort strip extending from the oral cushion along atleast a portion of the positioning accessory, the comfort strip creatinga generally soft boundary between at least a portion of the sensorpositioning accessory and the patient's oral cavity.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates one embodiment of an oral cushion for use with adigital radiographic sensor or x-ray film packet.

FIGS. 2–4 illustrate a mode for enclosing a wireless sensor or filmpacket within the oral cushion.

FIGS. 5–6 illustrate an integrated adhesive portion formed on the oralcushion that may be used to secure the sensor to an oral alignment orpositioning device.

FIGS. 7A–7B illustrates another embodiment of an oral cushion thatincorporates a drawstring securing mechanism for containment of thesensor within the oral cushion.

FIGS. 8A–8B illustrate a further embodiment of an oral cushion thatincorporates an elastic securing mechanism for containment of the sensorwithin the oral cushion.

FIGS. 9A–D, illustrate other embodiments of an oral cushion formed as acombination polybag with foam or cushioning material surrounding thepolybag on one or more sides.

FIG. 10 illustrates an embodiment of an oral cushion formed as acombination polybag with foam or cushioning material surrounding thepolybag at the opposing end from the opening.

FIGS. 11A–B illustrate another configuration of an oral cushion orcushioning barrier to be used with various-oral alignment or positioningdevices

FIG. 12 illustrates another configuration of an oral cushion whichcovers at least a portion of the sensor and the sensor within the oralcushion.

FIGS. 13A–B illustrates further configurations of an oral cushion havinga cushioning extension extending therefrom.

FIGS. 14A–B illustrates the use of the oral cushion in connection withthe sensor and positioning accessory when placed within the oral cavityof a patient.

FIGS. 15 and 16 illustrate a further embodiment of an oral cushion thatincorporates an elongated section designed to receive and contain awired or wireless sensor.

FIG. 17 illustrates a further embodiment of an oral cushion thatincorporates an elongated section constructed entirely of foam, softrubber or plastic tube designed to receive and contain a wired orwireless sensor.

DETAILED DESCRIPTION OF THE CERTAIN EMBODIMENTS

FIG. 1 illustrates one embodiment of an oral cushion 105 for use with aradiographic detection device or sensor 110. The sensor 110 comprises acomponent such as a digital radiographic sensor or conventional x-rayfilm packet configured to be inserted into a patient's oral cavity. Thesensor 110 may further comprise a digital detection device of a wired orwireless variety. Like conventional x-ray film, these devices may beused in oral imaging applications. Examples of digital detection devicesinclude computed dental radiography devices (CDRs) such as thoseproduced by Schick Technologies (Long Island City, N.Y.). It will beappreciated that the illustrated sensor 110 represents but one of manypossible sensor configurations and, as such, the oral cushion may beadapted for use with a variety of other sensor configurations withoutdeparting from the scope of the present teachings. In each of thevarious embodiments, the foam or adhesive may be printed with companynames to permit private labeling or with instructions for use.

The oral cushion 105 comprises a pocket portion 115 generally conformingto the shape and dimensions of the sensor 110 with an opening 113 intowhich the sensor 110 may be positioned within the pocket 115. Thecushioning barrier 105 may further comprise a flap section 125 formed tobe folded in such a manner so as to substantially enclose the sensor 110when inserted into the pocket 115. Enclosing the sensor 110 within theoral cushioning barrier 105 desirably reduces the risk of contaminationof the sensor 110 and further provides significant cushioning coverageabout the entirety of the sensor 110 as will be described in greaterdetail hereinbelow.

The flap section 125 of the sensor 110 may conform to variousconfigurations and include an adhesive portion 130 that secures the flapsection 125 in a desired position about the oral cushion 105 at leastpartially enclosing and securing the sensor 110 within the pocket 115.In one aspect, the flap section 125 comprises first and second wingsections 135, 140 joined to the pocket 115. When enclosing the sensor110, a top portion of the oral cushion 105 may be folded to cover theopening 113 in the pocket 115 with the first and second wing sections135, 140 further used to secure the top portion in a fixed position.Additional details of the sensor enclosing approach are discussed belowin connection with FIGS. 2–4.

In various embodiments, the oral cushion 105 may be fabricated from agenerally thin plastic or foam material capable of being folded andsecured in the aforementioned manner. In one aspect, forming the oralcushion 105 in part or whole from foam or similar material desirablyimparts a soft, supple, and/or comfort quality to the oral cushion 105.This feature desirably improves patient comfort when the sensor 110 isplaced within the oral cavity by substantially reducing or eliminatingtissue contact with sharp, rough or uncomfortable portions of the sensor110 or associated positioning accessory that the patient might otherwisefeel. Additionally, the oral cushion provides a generally soft layerbetween the oral tissue of the patient and the generally hard surface ofthe sensor 110 itself. In another aspect, the material used to form theoral cushion 105 may be scented, unscented, flavored or unflavored inorder to enhance the patient's overall experience. In particular, it isenvisioned that allowing the patient to select a particular scented orflavored oral cushion 105 would make the procedure more enjoyable forthe patient and would especially help to alleviate the fear of youngerpatients.

In another aspect, the materials used to form the oral cushion 105 maybe of different colors to allow the practitioner to differentiatebetween oral cushions 105 used in the anterior of the patient's mouthversus those used in the posterior of the patient's mouth. For example,blue colored oral cushions 105 may be used for the anterior sections ofthe patient's mouth and yellow colored oral cushions 105 may be used forthe posterior sections of the patient's mouth. Color-coded cushionsprovide for ease of use and minimize the risk of confusion.Alternatively, different color-coded oral cushions 105 may be used todistinguish between oral cushions 105 used on the left side of apatient's mouth versus those used on the right side of a patient'smouth.

Typically, the oral cushion 105 may be constructed using relativelyinexpensive manufacturing processes such that the cost per cushion 105is generally kept low. Furthermore, the barrier 105 may be used as adisposable component in the imaging process wherein the sensor 110 usedin connection with the cushion 105 does not necessarily require cleaningor sterilization between uses from one patient to the next. Providing amechanism for enclosing the sensor 110 in this manner reduces oralleviates potential contamination of the sensor 110 by patient salivaand transmission of germs, dirt, bacteria, and other undesirablecomponents. As will be appreciated by one of skill in the art, the oralcushion 105 of the present teachings further provides improvedcontainment and securing of the sensor 110 as compared to conventionalbarriers and may improve patient comfort through the use of the foam orcushioning material. In another aspect designed to minimize thetransmission of germs, the foam or soft material with which the oralcushion 105 is made, may be impregnated with an anti-bacterial oranti-microbial film.

FIGS. 2–4 illustrate another mode for enclosing the sensor 110 withinthe oral cushion 105. The sensor 110 is first inserted into the pocket115 (see FIG. 2) through the opening 113. At this point the sensor 110is partially enclosed within the pocket 115 and capable of being fullyenclosed when the opening 113 is closed. To accomplish this, the topportion of the oral cushion 105 may be configured to cover the opening113 by folding at least a portion of the top portion of the oral cushion105 to substantially enclose the sensor 110 within the oral cushion 105(see FIG. 3). In one aspect, the top portion of the oral cushion 105 isfolded against the opening 113 positioning the first and second wingsections 135, 140 in proximity to the pocket 115. Thereafter, the firstand second wing sections 135, 140 may be folded about the pocket 115,for example along the sides of the pocket, (see FIGS. 3–4) and securedin position by the adhesive portion 130. The result of these operationsat least partially seal the opening 113 and substantially enclose atleast a portion of the sensor 110 thereby forming a barrier layer aboutthe sensor 110 and preventing direct contact of the sensor 110 withexternal contaminants, fluids, or saliva. In the case of a wirelessdental sensor, the aforementioned enclosure approach may desirably sealsubstantially all portions of the wireless dental sensor within the oralcushion 105 providing an effective barrier against contamination and agenerally soft guard to patient tissue. Another embodiment has the oralcushion 105 shaped like an envelope with a single fold-over closingflap. A film, wireless sensor or wire equipped sensor 110 may beenclosed. In order to ensure complete protection from germs, saliva,etc., a plastic barrier or polybag may be used, to place the film, orsensor into, prior to placing it in the oral cushion 105. A retractiondevice may or may not be used as an additional safety measure to preventaccidental aspiration. An adhesive strip, 150, may be placed in anynumber of configurations on the external portion of the oral cushion 105for ease in attachment to positioning devices.

FIGS. 5A, B,–6 illustrate an integral adhesive positioning strip 150formed about the oral cushion 105. The adhesive positioning strip 150may be used to secure the oral cushion 105 (and at least partiallyenclosed sensor 160) to an oral alignment or positioning accessory suchas depicted at 5B 145 or 5A–6, 165. In one aspect, the adhesivepositioning strip 150 comprises a section of double-sided adhesive tape,foam, or the like which may be secured to a portion of the oral cushion105 on one side and to the oral alignment or positioning device, 145 or165 on the other side (see FIG. 6). The positioning accessory maycomprise a number of different accessories typically used for sensorpositioning including, by way of example, a bite tab 145, a bite plate165, an endodontic tab, an anterior periapical tab, a bitewing tab, aposterior periapical holder, or other such accessories that areconfigured to be secured to the sensor 110 with a desired alignment.

The adhesive positioning strip 150 may be located on the oral cushion105 in a variety of different locations to accommodate variousconfigurations of oral alignment or positioning devices 145, 165. Forexample, in one aspect, the adhesive positioning strip 150 may becentrally positioned along a front or back surface 166, 167 facilitatingproper positioning of the positioning device 165 with respect to thesensor 110. The size of the adhesive positioning strip 150 may furtherbe configured to generally conform to a contact area 168 of thepositioning device 165 that will be in contact with the oral cushion105. While the embodiments shown in FIGS. 5A–6 illustrate the adhesivepositioning strip 150 as being located on the back surface 166 of thecushion 105 it will be appreciated that the adhesive positioning strip150 may be positioned as necessary about the cushion to accommodatevarious configurations of positioning devices. For example, separateadhesive positioning strips 150 may be positioned along the front andback surfaces 166, 167 to give the user a choice of locations to securethe positioning device 145, 165. Additionally, the adhesive positioningstrip 150 may be oriented along one or more sides of the cushion 105depending on the configuration of the positioning device 145, 165.

In various embodiments, the adhesive positioning strip 150 may furthercomprise a removable liner or peel-off portion that covers and protectsthe adhesive portion prior to use. In one aspect, the liner comprises apaper or plastic layer (possibly treated with an anti-stick coating)that may be easily removed from the adhesive portion and allows thecushions 105 to be stored or stacked together without adherence to eachother. In various embodiments, the liner is of a commercially availabletype associated with the selected adhesive used in connection with thecushion 105. The adhesive positioning strip may be mounted on thecushion in either a parallel or perpendicular fashion with regards tothe longitudinal axis of the cushion. Further, the liner may be split soas to permit the removal of only a portion of the same exposing theadhesive incrementally; thus allowing continued use in opposing dentalquadrants.

Conventional barrier bags, sometimes used with digital sensors, lack asuitable adhesive portion for securing the aforementioned positioningaccessories and consequently must be used with more cumbersome basketholders which are typically less comfortable for the patient.Additionally, barrier bags fail to secure the sensor 110 in a desiredposition with respect to the positioning accessory 145, 165 andtherefore are not able to insure that the sensor 110 remains in adesired position with respect to the positioning accessory 145, 165. Thesecuring mechanism for aligning the sensor 110 with respect to thepositioning accessory 145, 165 is provided by use of the integraladhesive positioning strip 150 in connection with the cushioning barrier105 desirably facilitates the use of positioning accessories 145, 165without directly attaching them to the sensor 110 itself. Thus, thecomfort features and barrier qualities of the oral cushion 105 are notsignificantly impeded by the use of such accessories.

The oral cushion 105 may be desirably formed using a substantiallyseamless fabrication process wherein sharp, rough or generallyuncomfortable protrusions in the oral cushion 105 are minimized tofurther improve the comfort features of the oral cushion 105. It will beappreciated that construction of the oral cushion 105 in this manner maybe desirable to minimize surfaces that might potentially irritate tissuewithin the patient's oral cavity.

Furthermore, the oral cushion 105 may be constructed of a relativelythin material that does not significantly interfere with placement ofthe sensor 110 with respect to other oral alignment or positioningdevices 145, 165. For example, as will be described in greater detailhereinbelow, the oral cushion 105 may be used in connection with asensor basket, endodontic holder, or other sensor positioning accessorywithout appreciably impeding the ability of the sensor 110 to besecured, positioned, or oriented with respect to the positioningaccessory.

In various embodiments, the oral cushion 105 may comprise a compositestructure wherein a relatively thin material (e.g. plastic or polybag)is used in conjunction with foam or similar cushioning materialpositioned at strategic locations along the surface of the oral cushion105 where contact with patient tissue may occur. For example, one ormore of the edges or corners of the oral cushion 105 may be surrounded,contained, or overlaid by foam or similar cushioning material. Incertain embodiments, a single edge, corner, or surface of the oralcushion 105 may comprise the foam or cushioning material composition,whereas in other embodiments, more than one edge, corner, or surface ofthe oral cushion 105 may comprise the foam or cushioning materialcomposition. The positioning and size of the foam or cushioning materialin relation to the oral cushion 105 may therefore be represented bynumerous different constructions to accommodate various sizes andconfigurations of sensors 110.

FIGS. 7A–B illustrate another embodiment of a cushioning barrier 170that incorporates a drawstring mechanism for providing containment ofthe sensor 110 within the oral cushion 105. In the illustratedembodiment, the sensor 110 is placed within the oral cushion 105 throughthe pocket opening 113 and secured in position via a drawstring closure180. The drawstring closure 180 gathers the pocket opening 113 togethersuch that the oral cushion 105 at least partially encloses the sensor110 within the pocket 115. In a manner similar to the aforementionedembodiments, the generally sealed nature of the oral cushion 105desirably protects the sensor 110 from contamination allowing it to bere-used from one patient to the next. Furthermore, foam or similarcushioning material 182 may be strategically located about the oralcushion 105 to confer a protective benefit as previously described.

In one aspect, the strings 185 of the drawstring closure 180 may bedesirably configured to be of suitable length such that they extend outof the mouth of the patient. The relative length of the strings 185 maybe such that they serve as an anti-aspiration or anti-swallowing safetydevice wherein the sensor 110 may be quickly removed from the patient'smouth by grasping the strings 185 and retracting the enclosed sensor110. Alternatively, the strings 185 of the drawstring closure 180 may bedesirably configured to be relatively short in length to minimizeencumbrances due to the string presence. In various embodiments, thedrawstring closure 180 provides a convenient and rapid way to securelyenclose the sensor 110 without the use of adhesive material or tape. Aswith other previously described embodiments, the oral cushion 105 maydesirably include an adhesive positioning strip 150 for purposes ofjoining to a support or positioning apparatus. In a furtherconfiguration, the strings 185 of the drawstring closure may be formedfrom a moisture resistant or moisture-retardant material to preventundue accumulation of the patient's salvia or other liquids.

The oral cushion 105 may also comprise a generally soft sack or pouch(e.g. formed from foam or other suitable material) wherein the oralcushion 105 is sealed or closed at one end by gathering or collecting aportion of the sack with an elastic member in the general regionillustrated by the drawstring closure 180 shown in FIG. 7B. The elasticmember may be formed as an integral component of the oral cushion 105wherein the opening 113 expands to accommodate insertion of the sensor110 within the oral cushion 105 and subsequently contracts to thereby atleast partially enclose the sensor 110 providing a convenient mechanismby which to protect the sensor 110. As with other embodiments, the oralcushion 105 may be formed with an adhesive positioning strip present onthe surface of the oral cushion 105 to accommodate the use of variouspositioning and alignment devices.

In further embodiments shown in FIGS. 8A and 8B, the oral cushion 105may comprise a self-sealing covering having an adhesive portion 187which secures the opening 113 of the pocket 115 once the sensor 110 hasbeen inserted. In this configuration, the oral cushion 105 may comprisean inner member 188 (e.g. polybag or plastic material) having theadhesive portion 187 with an optional outer cushioning member 189 (e.g.foam or other generally soft material). The inner member 188 desirablyprovides a moisture resistant space to contain the sensor 110 keeping itgenerally dry and clean with the outer member 189 providing acomfortable cushion to prevent tissue abrasion.

As with other embodiments, the adhesive portion 187 may further comprisea removable liner or peel-off portion that covers and protects theadhesive component prior to use. In one aspect, the liner comprises apaper or plastic layer (possibly treated with an anti-stick coating)that may be easily removed from the adhesive portion 187 and preventsthe cushion 105 from becoming sealed until desired.

Enclosure of the sensor 110 within the aforementioned embodiment of thecushion 105 may be accomplished by inserting the sensor 110 within thepocket 115, removing the adhesive liner (if present), and depressing,pinching, or folding over the general area about the opening closed. Bythis operation, contact between portions of the cushion 105 is made suchthat the adhesive portion 187 effectively seals the opening 113 therebyprotecting the desired portions of the sensor 110.

Removal of the sensor 110 from the cushion 115 may be accomplished bypulling apart the region of the cushion 115 sealed by the adhesive andmay further be facilitated by the use of a resealable or non-permanentadhesive. Additionally, the cushion 115 may be grasped at a desiredlocation and torn or ripped to create an opening for the sensor 110 tobe removed. The generally, inexpensive construction of the cushion 105is such that it may be fabricated as a deposable product, however, theuse of a resealable or non-permanent adhesive in connection with theopening 113 or positioning accessories 165 may allow for a reusableproduct. This embodiment may or may not include a non-permeable barrierliner. It may be used alone or in conjunction with a sensor previouslyplaced in a barrier sheaf. The benefit of this embodiment is thecushioning effect and ease of positioning due to the employment of thepositioning strip used to secure positioning apparatus or a bite tab145.

FIGS. 9A–D illustrate other embodiments of the oral cushion 105 formedas a combination sack or bag (e.g. thin plastic polybag) with foam orcushioning material surrounding the sack on one or more sides 182. Inone aspect, the oral cushion 105 comprises the pocket section 115 joinedwith an elongated section 215. The sensor 110 is desirably inserted intothe elongated section 215 and pushed through until it resides within thepocket section 115. As with other embodiments, the sensor 110 may be ofa wireless type or a wired type as illustrated. In this particularimplementation, the wires 225 of the sensor 110 may be desirablyshielded from contamination along with the sensor 110 by the elongatedsection 215.

In certain embodiments, the oral cushion 105 comprises a drawstringenclosing mechanism 230 used to seal the sensor 110 and wires 225 withinat least a portion of the oral cushion 105. The drawstring enclosingmechanism 230 may be formed as a vertical, horizontal or spiraldrawstring which is attached to the oral cushion 105 at variouspositions. When the drawstring 236 is engaged the oral cushion 105collapses about the sensor 110 and wires 225 thereby collecting anyexcess material relatively closely about the sensor 110 and wires 225 toeffectively protect them from contamination and debris. As with otherembodiments, the adhesive positioning strip 150 may be utilized toenable the oral cushion 105 to be joined with a bite tab 145, biteplate, holder, or other component to which the sensor 220 may bedesirably affixed. It will be appreciated that the drawstring enclosingmechanism 230, illustrated in FIGS. 9A–B, may be omitted in certainembodiments or alternatively the drawstring may be implemented as ananti-aspiration device without necessarily providing the sealingfunctionality described above.

In certain embodiments, the construction of the oral cushion 105 may beaccomplished by hot stamp methods or the like in which the sides of theoral cushion 105 are joined to form the enclosable space within whichthe sensor 110 resides. Additionally, the oral cushion 105 may be formedin part or whole from thin plastic, foam, or a combination of materialsto provide generally soft surfaces 240 with little or no rough or sharpedges about the regions of the oral cushion 105 that may engage with themouth or tissue contained therein. For example, the construction of theoral cushion 105 may comprise a combination of materials wherein thepocket section 115 is formed from a selected material such as foam andthe elongated section 215 is formed from another material such asplastic or polybag material. All embodiments may or may not includeadhesive positioning strips 150 located on the exterior, so placed toease the attachment/detachment of various holding devices. Allembodiments may or may not include a bite tab which the patient wouldbite on or occlude, to hold the sensor or film and oral cushion inplace.

FIG. 10 illustrates an exemplary configuration of the oral cushion 105.In this configuration, the seamed or seamless elongated polybag tubing215 is joined to the cushion 105 by any of various methods. On theexternal face of the cushion, an adhesive positioning strip 150 may beapplied either perpendicular or parallel with the longitudinal axis ofthe device. The adhesive positioning strip may be divided in portions insuch a manner as to permit the removal of one or more strips ofprotective liner in order to expose the adhesive incrementally, thuspermitting the adhesion to various positioning devices. The techniciansimply slips the sensor 110, which may be equipped with a wire 225 or bewireless, into the opening 113, then slides the sensor forward into thecushion 105. The liner covering the adhesive positioning strip may thenbe removed to attach the cushion to a positioning device. After use, thesensor is removed and the device is discarded. The elongated nature ofthe device permits the shielding from saliva and various other debrisfrom the oral cavity from contact, therefore maintaining sterility whileproviding comfort to the patient during the x-ray process.

FIG. 11A illustrates another configuration of oral cushion 105 to beused in conjunction with a bite plate, carrier basket, or other deviceupon which or within which the sensor 110 is to be attached. In oneaspect, the oral cushion 105 comprises the pocket section 115 andoptionally the elongated section 215 similar to that described in FIGS.9–10. The sensor 110 is desirably inserted into the pocket section 115and sealed in any of various different manners exemplified in previousfigures.

In this configuration of the oral cushion 105, a padded section 320extends from the pocket section 115 for purposes of cushioning a biteplate, carrier basket, or other device to which the sensor 110 isattached. The padded section 320 may comprise one or more subsections325–335 that may be folded about the portions of the bite plate, carrierbasket, holder, etc. that engage with the tissue of the oral region.Providing the padded section 320 therefore provides a mechanism to coveror pad various portions of the external apparatus to which the sensor110 is to be contained or secured. In various embodiments, the paddedsection 320 may include an adhesive backing 340 that may be used tosecure the various subsections 325–335 of the padded section 320. Theoral cushion 105 of this configuration therefore desirably protects andpads the sensor 110 and also pads various other components which mayengage with the patient's tissue. Further illustration and descriptionof the placement and use of the oral cushion 105 is shown in connectionwith FIGS. 11B–12.

FIG. 11B depicts another configuration of the oral cushion 105 usedalone or in conjunction with a separate polybag tube 215 barrier shield.In this configuration, the oral cushion is a flat, thin piece of foam,plastic, rubber or other soft material that is coated on one side eitherpartially or completely with an adhesive, 340. The technician places thesensor 110 which may or may not be wireless, into the polybag tube orother barrier sheath. After removing the liner from the oral cushion,exposing the adhesive, the sensor within the polybag tube is placed onthe oral cushion. Either side is folded to the middle, completelyenclosing the sensor. The adhesive positioning strip 150 may or may notbe placed on either side of the closed flaps as well as on the back ofthe oral cushion for use in attaching the oral cushion to variouspositioning devices such as bite tabs 145. An additional variant on thisembodiment may or may not include the polybag or barrier sheathpre-attached to the oral cushion.

FIG. 12 illustrates still another configuration of the oral cushion 105having foldable tab sections 355 that may be desirably used to coverrough, sharp, or otherwise potentially uncomfortable sections of a biteplate, holder, or other device 360 used in connection with the sensor110 such that discomfort felt from these sections when in use by thepatient are reduced or minimized. In one aspect, the oral cushion 105 isconstructed to allow the sensor 110 to be inserted into the bite plate,holder or other device 360 without significant impediment. The foldabletab sections 355 may then be positioned in a manner that allows them tobe folded over various portions of the bite plate, holder or otherdevice 360. As previously noted, an adhesive layer 340 may be used inconnection with the tab sections 355 to facilitate securing them inposition providing an additional safety measure in preventing accidentalaspiration.

In an alternative embodiment, the oral cushion 105, comprising a pocketsection 115 with an opening 113 on either side and, optionally anelongated section 315 may be slipped over the sensor 110 when positionedwithin the bite plate, holder or other device 360. When so positioned,the pocket section 115 may be used to enclose the sensor 110 and atleast a portion of the bite plate, holder or other device 360 and theelongated section 315 may be used to cover other portions of the biteplate, holder, or other device 360 that may contain exposed edges,corners, or protrusions that may cause the patient discomfort. Incertain embodiments, the oral cushion 105 may further include one ormore slits that facilitate positioning the oral cushion over varioussensor holders.

FIGS. 13A–B illustrates other configurations of an oral cushion 105. Inone aspect, the oral cushion 105 comprises a foam or poly bag with foam405 present about one or more sides 407 that are generally closed orsealed. In one preferred embodiment, the foam 405 surrounds three sidesof the oral cushion 105 and the remaining side 415 is open to receivethe sensor 110 in the pocket 115. From the open side 415, the oralcushion 105 may be slipped over a sensor 110 and at least a portion of aholder, basket, bite plate, etc to which the sensor 110 is attached orsecured.

A comfort strip or portion of padding material 425 may further extendfrom a portion of the oral cushion 105 having an adhesive portion usedfor securing the oral cushion 105 to a sensor positioning accessorycomprising for example a sensor basket, endodontic holder, bite tab, orsensor positioning arm. Such a configuration of oral cushion 105 maydesirably be used in connection with conventional barrier bags toimprove the comfort of the patient when the sensor and holder are placedwithin the patient's mouth. In one aspect, the adhesive portion of thecomfort strip facilitates positioning of the cushioning projection aboutone or more contours associated with the sensor positioning accessoryand acts as an additional safety measure to prevent the patient fromaccidentally aspirating the oral cushion 105. Any embodiment that doesnot have the comfort strip 425 will be equipped with an adhesive safetystrip 150 in order to secure the oral cushion to the positioning deviceand therefore prevent accidental aspiration while supportingpositioning. (see FIG. 15A–B) As with other embodiments, a generallysoft padding material 405 may surround various portions of the oralcushion 105 to further improve patient comfort.

While, certain aforementioned embodiments have described the oralcushion 105 for use with various positioning devices and accessories165, 360 it will be appreciated that the oral cushion may additionallybe used without the positioning devices and accessories 165, 360. Forexample, in certain instances or modes of dental imaging, placement ofthe sensor 110 within the oral cavity does not necessarily require useof the positioning devices 165, 360 and can be accomplished either bythe patient positioning and retaining the sensor 110 manually or byplacement of the sensor 110 without the need for external retentionduring imaging. The ability to selectively utilize the adhesive portion150 as necessary or desired improves the flexibility of the oral cushionto accommodate various different imaging circumstances or situationsusing a singular cushion configuration.

FIGS. 14A and 14B illustrate examples of the placement of the dentalsensor 110 protected by the cushion 105 with various positioningaccessories 165, 360 within the oral cavity. Use of the oral cushion 105in connection with the dental sensor 110 desirably allows positioningand alignment of the dental sensor 110 in much the same way as is donewithout the cushion 105 being present. For example, as shown in FIG.14A, the dental sensor 110 is secured to the positioning accessory 360and is protected by the cushion 105 as previously described in FIG. 12.In one embodiment, foldable tab sections 355 may be used to covervarious portions of the positioning accessory 360 that might come intocontact with the patient's oral tissues. Alternatively the oral cushion105 may comprise the aforementioned elongated section 315 that may bepositioned in such a way as to substantially prevent contact between aportion of the positioning accessory 360 and the patient's oral cavity.When inserted into the patient's mouth, a portion 510 of the oralcushion 105 may extend along the positioning accessory 360 such thatthis portion 510 is intended to be bit down upon by the patient. Therelatively soft construction of this portion 510 of the cushion furtherimproves patient comfort during the imaging process.

In one mode of operation, use of the oral cushion 105 in connection withthe dental sensor 110 and positioning accessory 165, 360 results in thepositioning of the dental sensor 110 generally behind and adjacent to adesired portion of the patient's teeth. Specific alignment of the dentalsensor 110 is based upon the type of image to be taken or the portion ofthe patient's teeth to be imaged. The generally resilient nature of theoral cushion 105 is such that it may be used for a protracted period oftime wherein multiple images are acquired without significant concernover the breakdown of the barrier between the patient's tissue and thedental sensor. Additionally, the comfort provided by the oral cushion105 allows more images to be taken or more care and time to be put intoaligning the dental sensor 110 without causing the patient undo pain ordiscomfort during the imaging process.

As will be appreciated by one of skill in the art, application of theoral cushion 105 to the dental sensor 110 desirably protects that dentalsensor 110 from contact with the patient's saliva as shown in FIG.14A–B. Furthermore, the oral cushion 105 protects the patient fromdirect contact with the dental sensor 110 and various portions of thepositioning accessory 165, 360 thus reducing the likelihood of tissueinjury and patient discomfort during the imaging process.

FIG. 14B further illustrates the use of the oral cushion 105 inconnection with a dental sensor 110 and positioning accessory 165comprising a bite plate. As described above in connection with FIG. 14Athe dental sensor is substantially protected from contact with apatient's oral tissue and vice versa. Additionally, the location of theadhesive portion 150 of the oral cushion 105 is such that it aids in theproper alignment of the positioning accessory 165 with respect to thedental sensor 110 and further facilitates alignment of the dental sensor110 within the patient's oral cavity when the positioning accessory 165is bit down upon.

FIGS. 15 and 16 illustrate an embodiment of the oral cushion 105 formedof material that is gentle or soft to a patient's mouth, such asplastic, foam or cushioning material, having a front and a back sidewith a pocket section 115 disposed there between, the pocket section 115generally conforming to the shape and dimensions of the sensor 110 withan opening 113 into which the sensor may be positioned within the pocket115. An adhesive safety strip 160 is disposed along at least a portionof the oral cushion 105. This adhesive safety strip is critical topreventing the accidental aspiration of the oral cushion. After thetechnician places the sensor 110 into the elongated polybag tube 215,and thence into a holding device or basket 360, the protective paper orcovering is removed from the adhesive safety strip 160, exposing theadhesive. The entire sensor with holding device 360 attached may beplaced into the oral cushion pocket 115, and held in place by theadhesive safety strip 160. FIG. 15 shows an exploded view of the devicewith the individual portions revealed, while FIG. 16 shows the devicefully inserted into the oral cushion 105 as prepared for insertion intothe mouth of a patient. The elongated section 215 is generally made outof plastic or polybag material, but can be made of any softer material,such as plastic or foam, that is suitable to secure the wire 115 and becomfortable to the touch of a patient. Plastic material is suitable forthe elongated section 215 because after the sensor 110 and wire 225 areinserted, the elongated section (manufactured of suitable plastic) canbe pressed and compressed upon itself to reduce the size of material tobe inserted into the patient's mouth.

The front and back side of the oral cushion 105 may be sealed or foldedtogether on one or more sides while one side may be left open orunsealed. An adhesive safety strip 160 may be placed on the front,inside and/or back portions of the oral cushion 105 to secure theposition of the sensor 110 within the oral cushion 105 and to secure thecushion 105 within a positioning accessory 165, 360. By inside portionof the oral cushion 105, it is meant the interior portions of the pocketsection 115. FIG. 15 shows the adhesive safety strip positioned on thefront, inside portion of oral cushion 105 and as a single adhesivesafety strip. An additional embodiment where the adhesive safety strip160 is divided into multiple (such as two) sections that can beindividually exposed with removal of a removable liner or peel-offportion that covers and protects the adhesive strip component prior touse is also clearly envisioned. It will, therefore, be appreciated thedevice of the invention includes various embodiments wherein theadhesive safety strip 160 can be in one or multiple sections and can bepositioned on the front and/or back of the oral cushion 105, dependingupon the desires of the practitioner using the device.

In order to aid in easy placement of sensor 110, the front and backsides of the oral cushion 105 may be of the same or different lengths.If equal or approximately equal lengths of material are used to form thefront and back sides of the oral cushion 105, a slit may be madeapproximately half way up one or both sides of the oral cushion 105 toaccommodate the sensor 110. In the embodiment shown in FIGS. 15 and 16,one side of the oral cushion 105 is larger (longer) than the other sideof the oral cushion. However, the front and backsides of the oralcushion 105 may be fashioned in varying lengths to -accommodate the manysizes of x-ray film and dental sensors. Either side may or may notinclude an adhesive positioning strip or bite tab.

The sensor 110 is desirably inserted into the elongated section 215 andpushed through until it resides within the pocket section 115. As withother embodiments, the sensor 110 may be of a wireless type or a wiredtype as illustrated. In this particular implementation, saliva, germsand other oral contaminants are prevented from directly contacting thewires 225 of the sensor 110 or the sensor 110 itself by the elongatedsection 215.

FIG. 17 represents another embodiment of the oral cushion 105. In thisembodiment, the entire body of the oral cushion 105, to include theelongated portion, is made from a soft foam, plastic or rubber materialthat fully encloses the sensor 110 on three sides in a tube. In order toease alignment of the sensor 110, a sensor alignment line is provided onthe oral cushion 105. An adhesive positioning strip, 150, is provided onone or more sides, positioned perpendicular or parallel to thelongitudinal axis of the oral cushion, 105, in order to ease theattachment of various positioning devices.

While use of the oral cushion 105 in connection with the dental sensor110 and positioning accessory 165 is shown in two modes, it will beappreciated that other operational modes exist and thus the use of theoral cushion 105 should not be construed to be limited to thoseillustrated. Additionally, various embodiments of the oral cushion 105have been described and illustrated that may be used in connection witha variety of different dental sensor 110 and positioning accessoryconfigurations. As such, each of these combinations is conceived to bebut other embodiments of the present teachings.

Although the foregoing description of the present teachings has shown,described and pointed out novel features of the invention, it will beunderstood that various omissions, substitutions, and changes in theform of the detail of the apparatus as illustrated, as well as the usesthereof, may be made by those skilled in the art without departing fromthe spirit of the present invention. Consequently the scope of thepresent teachings should not be limited to the foregoing discussion butshould be defined by the Claims.

1. An intra-oral dental comfort device capable of being configured foruse with or without a positioning accessory, the device comprising: anoral cushion having first and second sides with a pocket disposedtherebetween, the pocket dimensioned to receive and maintain a dentalsensor in a generally secure position within the oral cushion, the oralcushion further configured to provide a comfort barrier between at leasta portion of the dental sensor and tissue in a patient's oral cavity; anadhesive safety strip disposed along at least a portion of the oralcushion to secure an elongated section to the oral cushion wherein saidelongated section is designed to receive a dental sensor or film; and anadhesive positioning strip disposed along at least a portion of the oralcushion, the adherent member configured to receive and secure thepositioning accessory to the oral cushion such that the dental sensormay be positioned in a desired orientation within the patient's oralcavity allowing imaging of at least a portion of the patient's teeth byan imaging device used in connection with the dental sensor.
 2. Theintra-oral dental comfort device of claim 1, wherein the dental sensorconsists of a digital x-ray sensor or an x-ray film packet.
 3. Theintra-oral dental comfort device of claim 2 wherein, the oral cushion isconfigured to accommodate wireless or wired digital x-ray sensors orfilm.
 4. The intra-oral dental comfort device of claim 1, wherein theoral cushion is formed from a soft or malleable material generallyresistive to tissue abrasion.
 5. The intra-oral dental comfort device ofclaim 4, wherein the oral cushion composition comprises foam, plastic,rubber, or paper.
 6. The intra-oral dental comfort device of claim 1wherein, the positioning accessory comprises a bite plate, a bite tab,an endodontic tab, an anterior periapical tab, a bitewing tab, aposterior periapical holder, a sensor basket, an endodontic holder, filmpositioning device, or a sensor positioning arm used for positioning thedental sensor within the patient's oral cavity.
 7. The intra-oral dentalcomfort device of claim 1 wherein, the adhesive positioning stripcomprises an adhesive component that allows the positioning accessory tobe removably secured to the oral cushion or permanently attached anddisposed of with a positioning device.
 8. The intra-oral dental comfortdevice of claim 1, wherein the elongated section is formed from aplastic or polybag material.
 9. The intra-oral dental comfort device ofclaim 1 wherein the oral cushion is sized to accommodate an oral sensorcontained within a sensor sheath or sensor holder.
 10. The intra-oraldental comfort device of claim 1 wherein, the oral cushion is formed soas to lack sharp or rough seams that might otherwise abrade portions ofthe patient's oral cavity.
 11. The intra-oral dental comfort device ofclaim 1, wherein at least two of the edges formed by the first andsecond sides of the oral cushion are sealed.
 12. The intra-oral dentalcomfort device of claim 1, wherein the first and second sides of theoral cushion are of equal or different length.
 13. The intra-oral dentalcomfort device of claim 4, wherein the material is colored, clear,opaque, scented, unscented, flavored or unflavored.
 14. The intra-oraldental comfort device of claim 1, wherein said adhesive positioningstrip comprises one or more removable liner portions to cover theadhesive when not in use, said liner portions being indirectly removableto permit exposure of the adhesive.
 15. The intra-oral dental comfortdevice of claim 8, wherein the edges of said elongated section areformed of or covered with foam to avoid tissue abrasion.